Asset profile
ACI-35.030
Vaccine
Evidence outlook · lead readout
NCT04445831 · Alzheimer's Disease, Cognitive Impairment, Tauopathies, Mild Cognitive Impairment, Dementia, Brain Diseases, Central Nervous System Diseases
The completed lead evidence is positive, with design limits that temper confidence — see the rationale below for exactly which.
NCT04445831: This was a randomized, quadruple-blinded, placebo-controlled study, which is a strong design foundation, but the enrollment was very small (57 participants split across seven arms, several with only 4-6 subjects), and the primary endpoints were safety/tolerability counts and antibody-titer levels rather than a hard clinical or cognitive outcome - cognitive and functional scales (CDR-SB, RBANS, NPI) were only exploratory and their results were not even posted. Because the primary comparisons here are immunogenicity/safety readouts rather than a statistically tested clinical efficacy endpoint, this evidence is real but limited.
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